© 1999


Controlled Efficacy Studies and Regulation

  • P. Elsner
  • Howard I. Maibach
  • Hans F. Merk

Table of contents

  1. Front Matter
    Pages I-XVI
  2. General Background

  3. Efficacy

    1. Front Matter
      Pages 55-55
    2. R. L. Rizer
      Pages 81-91
    3. J. E. Wild, J. P. Bowman, L. P. Oddo
      Pages 107-115
    4. B. Gabard
      Pages 116-134
    5. S. B. Levy
      Pages 135-139
    6. U.-F. Haustein, P. Nenoff
      Pages 140-155
    7. H. Zhai, H. I. Maibach
      Pages 156-166
    8. C. Rona, E. Berardesca
      Pages 167-174
    9. E. Berardesca, H. I. Maibach
      Pages 187-196
    10. V. Wienert
      Pages 209-214

About this book


th Together with the 6 Amendment - Council Directive 93/35 EEC - to the Cosmetic Directive 76/768 EEC it was the first time that, according to Article 7b, special claims of efficacy could be legally attributed to cosmetic products but under the obligation to make evidence of the claimed effects; also an entirely new "controller" was introduced - the independent "safety assessor", This indeed means not only progress in reliable and honest marketing arguments but above all transparency as to the respective proof and thus protection of consumer's health. Such claims demand high standards in scientifi­ cally based methodology and their results in order to prove such demands evidently. There are also within the 6" Amendment to the Cosmetic Directive in Article 4a strict restrictions as to the further use of conventional animal testing for cosmetic pro­ ducts and their ingredients and especially for finished products. Without doubt there is a competition between the necessity and expectations on consumer health on the one hand and the requirements of acknowledged protection of animals as done in Council Directive 86/609 EEC on the other. But at least, based on the present state of knowledge, tests in human beings cannot replace animal testing in all instances. Not only ethical reasons alone prohibit or impede testing in humans but also very often the lack of knowledge on functional and/or biological processes underlaying observed effects with the consequence that suitable experimental methodologies are missing.


ageing aging allergen allergy cosmetics mutagen research safety skin toxicity

Editors and affiliations

  • P. Elsner
    • 1
  • Howard I. Maibach
    • 2
  • Hans F. Merk
    • 3
  1. 1.Klinikum der Friedrich Schiller-Universität Jena Klinik für HautkrankheitenJenaGermany
  2. 2.Department of DermatologyUniversity of California San Francisco School of MedicineSan FranciscoUSA
  3. 3.Rheinisch-Westfälische Technische Hochschule Aachen HautklinikAachenGermany

Bibliographic information

  • Book Title Cosmetics
  • Book Subtitle Controlled Efficacy Studies and Regulation
  • Editors P. Elsner
    Hans F. Merk
    Howard I. Maibach
  • DOI
  • Copyright Information Springer-Verlag Berlin Heidelberg 1999
  • Publisher Name Springer, Berlin, Heidelberg
  • eBook Packages Springer Book Archive
  • Hardcover ISBN 978-3-540-64047-9
  • Softcover ISBN 978-3-642-64160-2
  • eBook ISBN 978-3-642-59869-2
  • Edition Number 1
  • Number of Pages XVI, 315
  • Number of Illustrations 36 b/w illustrations, 16 illustrations in colour
  • Topics Pharmacology/Toxicology
  • Buy this book on publisher's site
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